Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must be taking: Insulin
Must not be taking: Hydroxyurea
Disqualifiers: Type 1 diabetes, Visual impairment, Pregnancy, Cardiovascular disease, others
Trial Summary
What is the purpose of this trial?This trial studies how a new technology can help people with diabetes who have had a kidney transplant manage their blood sugar levels more effectively. The technology provides constant data on blood sugar, allowing for better management.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking hydroxyurea.
What data supports the effectiveness of the treatment Dexcom G6 Continuous Glucose Monitoring System for diabetes management after kidney transplant?
The Dexcom G6 Continuous Glucose Monitoring System has shown consistent and acceptable accuracy in various settings, such as during elective abdominal surgery and in pediatric patients with Type 1 Diabetes, indicating its potential usefulness in managing blood sugar levels. Additionally, a modified algorithm for the Dexcom G6 improved data availability, which may enhance patient experience and integration into insulin delivery systems.
12345Is the Dexcom G6 CGM System safe for use in humans?
The Dexcom G6 CGM System has been evaluated in various studies and shown to be generally safe for use in humans. In a study during elective abdominal surgery, no clinically significant adverse events were reported, and the device showed consistent accuracy. Additionally, an analysis of FDA adverse events indicated that while there were some complaints about inaccuracy, no major safety concerns were highlighted.
12567How is the Dexcom G6 treatment unique for managing diabetes after a kidney transplant?
The Dexcom G6 is a continuous glucose monitoring (CGM) system that provides real-time glucose readings without the need for frequent finger pricks, making it easier to manage blood sugar levels after a kidney transplant. It offers consistent accuracy and increased data availability, which can improve glucose management and patient experience compared to traditional methods.
12358Eligibility Criteria
This trial is for adults over 18 with Type 2 Diabetes who use insulin and have had a kidney transplant within the last year. Participants need functioning kidneys, access to home Wi-Fi, and must be able to test their blood sugar four times daily if using the blinded CGM. It's not for those with Type 1 Diabetes, unstable heart disease, active cancer treatment, significant visual or cognitive issues, or women who are pregnant/breastfeeding.Inclusion Criteria
I am 18 years old or older.
Access to home wi-fi connection
I have Type 2 Diabetes and am taking insulin.
+2 more
Exclusion Criteria
I have heart problems that are not well-controlled.
Prisoners
You are not able to wear the Dexcom G6 device all the time for any reason.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants will either use continuous glucose monitoring (CGM) or self-monitoring of blood glucose (SMBG) for glycemic control
10 weeks
Regular monitoring with CGM or SMBG
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study examines how continuous glucose monitoring (CGM) affects blood sugar control in diabetic kidney transplant patients. The Dexcom G6 device will be used to monitor glucose levels continuously to see if it helps maintain them within a target range.
2Treatment groups
Active Control
Placebo Group
Group I: Continuous glucose monitoring (CGM)Active Control1 Intervention
Those in the intervention arm will wear a continuous glucose monitoring device. They only need to perform blood glucose fingersticks if the CGM transmission is lost for a prolonged period of time or in cases of hypo- or hyperglycemia when symptoms don't align with blood glucose readings.
Group II: Self monitoring of blood glucose (fingersticks)Placebo Group1 Intervention
The control arm will remain on standard-of-care SMBG while the intervention arm will use their CGM. The control arm utilizing SMBG will be required to have at minimum 4 glucose checks per day.
Dexcom G6 is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Dexcom G6 for:
- Type 1 diabetes
- Type 2 diabetes
- Glycemic control in diabetic patients
🇪🇺 Approved in European Union as Dexcom G6 for:
- Type 1 diabetes
- Type 2 diabetes
- Glycemic control in diabetic patients
🇨🇦 Approved in Canada as Dexcom G6 for:
- Type 1 diabetes
- Type 2 diabetes
- Glycemic control in diabetic patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC Davis HealthSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
Dahlia M ZuidemaLead Sponsor
DexCom, Inc.Industry Sponsor
References
The Accuracy of Continuous Glucose Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA Study). [2023]Objectives: Real-time and intermittently scanned continuous glucose monitoring are increasingly used for glucose monitoring in people with diabetes requiring renal replacement therapy, with limited data reporting their accuracy in this cohort. We evaluated the accuracy of Dexcom G6 and Abbott Freestyle Libre 1 glucose monitoring systems in people with diabetes undergoing hemodialysis. Methods: Participants on hemodialysis with diabetes (on insulin or sulfonylureas) were recruited. Paired sensor glucose from Dexcom G6 and Freestyle Libre 1 were recorded with plasma glucose analyzed using the Yellow Springs Instrument (YSI) method at frequent intervals during hemodialysis. Analysis of accuracy metrics included mean absolute relative difference (MARD), Clarke error grid (CEG) analysis and proportion of CGM values within 15% and 20% or 15 and 20 mg/dL of YSI reference values for blood glucose >100 or ≤100 mg/dL, respectively (% 15/15, % 20/20). Results: Forty adults (median age 64.7 [60.2-74.4] years) were recruited. Overall MARD for Dexcom G6 was 22.7% (2656 matched glucose pairs), and 11.3% for Libre 1 (n = 2785). The proportions of readings meeting %15/15 and %20/20 were 29.1% and 45.4% for Dexcom G6, respectively, and 73.5% and 85.6% for Libre 1. CEG analysis showed 98.9% of all values in zones A and B for Dexcom G6 and 99.8% for Libre 1. Conclusions: Our results indicate Freestyle Libre 1 is a reliable tool for glucose monitoring in adults on hemodialysis. Further studies are required to evaluate Dexcom G6 accuracy in people on hemodialysis.
A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]The algorithm for the Dexcom G6 CGM System was enhanced to retain accuracy while reducing the frequency and duration of sensor error. The new algorithm was evaluated by post-processing raw signals collected from G6 pivotal trials (NCT02880267) and by assessing the difference in data availability after a limited, real-world launch. Accuracy was comparable with the new algorithm-the overall %20/20 was 91.7% before and 91.8% after the algorithm modification; MARD was unchanged. The mean data gap due to sensor error nearly halved and total time spent in sensor error decreased by 59%. A limited field launch showed similar results, with a 43% decrease in total time spent in sensor error. Increased data availability may improve patient experience and CGM data integration into insulin delivery systems.
Patient and nursing experience of flash glucose monitoring following kidney transplantation. [2023]Flash glucose monitoring (FGM) is increasingly used for blood glucose assessment due to ease of use and is now subsidized in Australia for blood glucose measurement for patients with Type 1 Diabetes Mellitus. Dysglycaemia is common following kidney transplantation and is associated with worse outcomes and there are data to support the use of FGM post-transplant to better detect and manage changes in blood glucose levels. There is, however, no data on patient or staff perceptions of FGM, or resource implications in this setting. We prospectively evaluated patients and nursing staff experiences of FGM compared to traditional capillary glucose measurement in the immediate post-transplant setting, along with resource utilization, cost of testing, staff time taken to test and accuracy. Twenty-one kidney transplant recipients had a FGM sensor applied in the post-operative period and results compared to capillary blood glucose monitoring (CBGM) measured at least four times a day. Six-hundred-fifty-six glucose measurements were obtained, median per patient of 30 readings (IQR 10). Pearson's correlation between FGM and CBGM readings is 0.95 (p
Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]The perceived value and consistent use of continuous glucose monitoring (CGM) systems depends in part on their accuracy. We assessed the performance of a sixth-generation CGM system (Dexcom G6) in children and adolescents.
Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. [2021]We assessed the performance of the factory-calibrated, sixth-generation continuous glucose monitoring (CGM) system Dexcom G6® (DexCom Inc., San Diego, California) during elective abdominal surgery. Twenty adults with (pre)diabetes undergoing abdominal surgery (>2 hours; 15 men, age 69 ± 13 years, glycated haemoglobin 53 ± 14 mmol/mol) wore the sensor from 1 week prior to surgery until hospital discharge. From induction of anaesthesia until 2 hours post-surgery, reference capillary glucose values were obtained every 20 minutes using the Accu-Chek® Inform II meter (Roche Diabetes Care, Mannheim, Germany). The primary endpoint was the mean absolute relative difference (ARD) between sensor and reference method during this period. In total, 1207 CGM/reference pairs were obtained. In the peri-operative period (523 pairs), mean ± SD and median (interquartile range [IQR]) ARD were 12.7% ± 8.7% and 9.9 (6.3;15.9)%, respectively, and 67.4% of sensor readings were within International Organization of Standardization 15197:2013 limits. CGM overestimated reference glucose by 1.1 ± 0.8 mmol/L (95% limits of agreement -0.5;2.7 mmol/L). Clarke error grid zones A or B contained 99.2% of pairs (A: 78.8%; B: 20.4%). The median (IQR) peri-operative sensor availability was 98.6 (95.9;100.0)%. No clinically significant adverse events occurred. In conclusion, the Dexcom G6 device showed consistent and acceptable accuracy during elective abdominal surgery, opening new avenues for peri-operative glucose management.
Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. [2018]This study was designed to evaluate accuracy, performance, and safety of the Dexcom (San Diego, CA) G4(®) Platinum continuous glucose monitoring (CGM) system (G4P) compared with the Dexcom G4 Platinum with Software 505 algorithm (SW505) when used as adjunctive management to blood glucose (BG) monitoring over a 7-day period in youth, 2-17 years of age, with diabetes.
An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]US Food and Drug Administration adverse event data for 2019 were analyzed for two insulin pumps and two continuous glucose monitors (CGMs). The analyses were selective-they were guided by the text described in the adverse events. They included (1) percent using auto mode for the Medtronic 670G pump, (2) distributions of hyper and hypo glucose values for Medtronic and Tandem pumps, (3) a Parkes error grid for Dexcom CGM vs glucose meter when the complaint was inaccuracy, and (4) the most frequent events for Abbott Freestyle. We found that for the 670G pump, there were more hypo events when auto mode was on than when auto mode was off. With Dexcom CGMs, users complained about inaccurate result when most results were in the B zone. With the Abbott Freestyle, the most frequent adverse event was an allergic skin reaction.
Continuous Glucose Monitoring in the Intensive Care Unit Following Total Pancreatectomy with Islet Autotransplantation in Children: Establishing Accuracy of the Dexcom G6 Model. [2022]Hyperglycemia is detrimental to postoperative islet cell survival in patients undergoing total pancreatectomy with islet autotransplantation (TPIAT). This makes continuous glucose monitoring (CGM) a useful management tool. We evaluated the accuracy of the Dexcom G6 CGM in pediatric intensive care unit patients following TPIAT. Twenty-five patients who underwent TPIAT had Dexcom G6 glucose values compared to paired serum glucose values. All paired glucose samples were obtained within 5 minutes of each other during the first seven days post TPIAT. Data were evaluated using mean absolute difference (MAD), mean absolute relative difference (MARD), %20/20, %15/15 accuracy, and Clarke Error Grid analysis. Exclusions included analysis during the CGM "warm-up" period and hydroxyurea administration (known drug interference). A total of 183 time-matched samples were reviewed during postoperative days 2-7. MAD was 14.7 mg/dL and MARD was 13.4%, with values of 15.2%, 14.0%, 12.1%, 11.4%, 13.2% and 14.1% at days 2, 3, 4, 5, 6 and 7, respectively. Dexcom G6 had a %20/20 accuracy of 78%, and a %15/15 accuracy of 64%. Clarke Error Grid analysis showed that 77% of time-matched values were clinically accurate, and 100% were clinically acceptable. The Dexcom G6 CGM may be an accurate tool producing clinically acceptable values to make reliable clinical decisions in the immediate post-TPIAT period.